drugset / Trial / NCT02264873
Phase I, Dose Escalation Study of Decitabine
NaSingle-groupOpen-labelTreatment
Summary
Decitabine is a hypomethylating agent that has shown significant anti-leukemic effect in Myelodysplastic Syndrome (MDS) and Acute Myeloblastic Leukemia (AML). This study is based on the hypothesis that Decitabine delivered after allo-hematopoietic stem cell transplant (HSCT) in patients with leukemia will enhance disease control by the allogeneic immune system and lead to a longer disease free survival. The study is designed to provide safety data of low-dosing in the post-transplant setting.
Timeline
- Start
- 2014-10
- Primary completion
- 2016-10
- Completion
- 2018-09-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Decitabine | Small molecule | 5 mg | — |
| Subject | Decitabine | Small molecule | 7.5 mg | — |
| Subject | Decitabine | Small molecule | 10 mg | — |
| Subject | Decitabine | Small molecule | 12.5 mg | — |